Clinical Trial Protocol Iranian Registry of Clinical Trials
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Clinical Trial Protocol Iranian Registry of Clinical Trials 30 Sep 2021 Comparative Effectiveness of Resistance Training With and Without Finger Movement Exercises on Hand Grip Strength and Hand Function in Elderly Population Protocol summary IRCT registration number: IRCT20200720048148N1 Registration date: 2020-09-05, 1399/06/15 Study aim Registration timing: retrospective The aim of this study is to check the effectiveness of finger movement exercises on hand grip strength and hand function among elderly individuals. Last update: 2020-09-05, 1399/06/15 Design Update count: 0 A randomized, double blinded clinical trial having parallel Registration date group design of 24 patients. 2020-09-05, 1399/06/15 Settings and conduct Registrant information Subjects of study from • Old Shelter Home Faisalabad. • Name Faisal Islam Foundation (old citizen), Faisalabad. • Hira Zahid Fatima foundation, Faisalabad will be considered. Name of organization / entity Participants/Inclusion and exclusion criteria The University of Faisalabad Inclusion criteria Individuals who will be willing to Country participate by signing consent form, Male and female Pakistan age ≥ 65 years, Conscious and able to communicate, No Phone defect in upper extremity and able to give us +92 41 8753585 measurement of hand grip strength, No disease that Email address cause restriction to individual to perform exercise, Ability [email protected] to remain in sitting position Exclusion criteria Severe impairment in cognitive function, Severe arthritis, Recruitment status Fracture and nerve injury in upper extremity, Any chronic Recruitment complete illness, Systemic disease including diabetes and Funding source hypertension Intervention groups Expected recruitment start date Group A will receive resistance exercise with hand 2020-07-22, 1399/05/01 gripper as a baseline treatment and Group B will receive Expected recruitment end date Finger movement exercises in addition to baseline 2020-09-01, 1399/06/11 treatment of resistance exercise. Actual recruitment start date Main outcome variables empty Primary outcome will be Hand grip strength and Actual recruitment end date secondary outcome will be Hand function empty Trial completion date General information empty Reason for update Scientific title Acronym Comparative Effectiveness of Resistance Training With IRCT registration information and Without Finger Movement Exercises on Hand Grip 1 Strength and Hand Function in Elderly Population Ethics committees Public title Compare effect of two exercises on hand grip strength in 1 old age Ethics committee Purpose Name of ethics committee Treatment Ethics committee of The University of Faisalabad Inclusion/Exclusion criteria Street address Inclusion criteria: Sargodha Road, University Town, Faisalabad. Individuals who were willing to participate by signing City consent form Male and female age 65 -95 years Faisalabad Conscious and able to communicate No defect in upper Postal code extremity and able to gave us measurement of hand grip 38000 strength No disease that cause restriction to individual to Approval date perform exercise Ability to remain in sitting position 2020-02-13, 1398/11/24 Exclusion criteria: Ethics committee reference number Severe impairment in cognitive function Severe arthritis TUF/DR/DPT/070 Fracture and nerve injury in upper extremity Any chronic illness. Systemic disease including diabetes and hypertension. Health conditions studied Age From 65 years old to 95 years old 1 Gender Both Description of health condition studied Loss of hand grip strength in old age Phase ICD-10 code N/A ICD-10 code description Groups that have been masked Participant Primary outcomes Outcome assessor Sample size 1 Target sample size: 25 Description Randomization (investigator's opinion) Hand grip strength Randomized Timepoint Randomization description Before intervention and after 4 weeks of Convenient sampling technique will be used to collect interventionCAMP sample and this sample will be allocated into two groups Method of measurement by lottery method of randomization. First of all we will CAMRY Hand Held Dynamometer collect sample from our place of convenience on the basis inclusion/exclusion criteria. After that, we will write names of each participant on page, close them and will Secondary outcomes ask the 3rd person to choose 12 closed pages and place them on side and then we will allocate them to treatment 1 and control groups without opening the pages. Blinding (investigator's opinion) Description Double blinded Hand function Blinding description Timepoint In our study participants and outcome assessor who will Before and after 4 weeks of intervention give treatment to participants are blinded to avoid Method of measurement biasness at any level.Blinding means both participants Dorouz Hand Index (DHI) and assessors are unaware of results of intervention. They don't know whether the treatment is effective or Intervention groups not. Placebo 1 Not used Assignment Description Parallel Intervention group:will receive resistance exercise with Other design features hand gripper as a baseline treatment. In addition to baseline treatment this group will also receive a set of Secondary Ids finger movement exercises that we includes pinching, filliping, crooking, finger counting and pressing. Each empty movement will be repeated 20 times in a single session. 2 These exercises will be performed in 3 sessions per week Old Shelter Home, Faisalabad for total of 4 weeks. Full name of responsible person Category Umair Rehabilitation Street address Narwala Road, Opposite Jawad Club, Faisalabad, 2 City Faislabad Description Postal code Control group:will receive resistance exercise with hand 38000 gripper as a baseline treatment. The individuals will be in Phone sitting position and asked to compress both arms of hand +92 41 4080554 gripper with maximum force. This resistance exercise for Email intrinsic hand muscles will be performed for both right [email protected] and left hands with four sets of 10 repetitions. Each set has resting interval of 2 minutes. This exercise has three sessions per week for 4 weeks. Sponsors / Funding sources Category Rehabilitation 1 Sponsor Recruitment centers Name of organization / entity The University of Faisalabad 1 Full name of responsible person Dr. Nimra Arshad; PT Recruitment center Street address Name of recruitment center Sargodha Road, University Town, Faisalabad Faisal Islam Foundation (old citizen), Faisalabad. City Full name of responsible person Faisalabad Faisal Islam Postal code Street address 38000 351/C, Batala Colony, Faisalabad Phone City +92 41 8868326 Faisalabad Fax Postal code +92 41 8868220 38000 Email Phone [email protected] +92 41 5348289 Web page address Email https://www.tuf.edu.pk faisalislamfoundation @gmail.com Grant name Web page address Grant code / Reference number Is the source of funding the same sponsor 2 organization/entity? Yes Recruitment center Title of funding source Name of recruitment center The University of Faisalabad Fatima foundation, Faisalabad Proportion provided by this source Full name of responsible person 100 Asma Awan Public or private sector Street address Private House# 4, Street# 7, Gulbahar colony, Satiana road, Domestic or foreign origin Faislabad Foreign City Category of foreign source of funding Faisalabad Sponsor: country of origin Postal code Country of origin 38000 PK Phone +92 41 7614661 Type of organization providing the funding Email Academic [email protected] Person responsible for general inquiries 3 Contact Recruitment center Name of organization / entity Name of recruitment center The University of Faisalabad 3 Full name of responsible person Person responsible for updating data Hira Zahid Position Contact Student Name of organization / entity Latest degree The University of Faisalabad Bachelor Full name of responsible person Other areas of specialty/work Hira Zahid Physiotherapy Position Street address Student P-63, Judicial Housing Society, Sheikhupura road, Latest degree Faisalabad Bachelor City Other areas of specialty/work Faisalabad Physiotherapy Province Street address Punjab P-63, Judicial Housing Society, Sheikhupura road, Postal code Faisalabad. 38000 City Phone Faisalabad +92 41 8753585 Province Email Punjab [email protected] Postal code 38000 Phone Person responsible for scientific +92 41 8753585 inquiries Email [email protected] Contact Name of organization / entity Sharing plan The University of Faisalabad Full name of responsible person Deidentified Individual Participant Data Set (IPD) Hira Zahid Undecided - It is not yet known if there will be a plan to Position make this available Student Study Protocol Latest degree Undecided - It is not yet known if there will be a plan to Bachelor make this available Other areas of specialty/work Statistical Analysis Plan Physiotherapy Undecided - It is not yet known if there will be a plan to Street address make this available P-63, Judicial Housing Society, Sheikhupura road, Informed Consent Form Faisalabad. Undecided - It is not yet known if there will be a plan to City make this available Faisalabad Clinical Study Report Province Undecided - It is not yet known if there will be a plan to Punjab make this available Postal code Analytic Code 38000 Undecided - It is not yet known if there will be a plan to Phone make this available +92 41 8753585 Data Dictionary Email Undecided - It is not yet known if there will be a plan to [email protected] make this available 4.